Back to resultsEffect of High-Dose NAC on Patients With DPN (NAC)
Primary Purpose
Diabetic Neuropathies
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility Criteria
Inclusion Criteria:
- Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
- Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).
Exclusion Criteria:
- Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
- Cancer patients.
- Anyone having hypersensitivity to N-acetylcysteine.
- Anyone already taking N-acetylcysteine.
Sites / Locations
- Demerdash HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group 1, NAC group
Group 2, Control group
Arm Description
Group 1, NAC group (n=30): Patients will receive conventional therapy for diabetic neuropathy in addition to High Dose N-acetyl cysteine (2400 mg/day divided into two doses) daily for 3 months
Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.
Outcomes
Primary Outcome Measures
Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
Inflammatory marker
Concentration of Tumor necrosis factor alpha
Inflammatory marker
Concentration of Glutathione peroxidase
Oxidative stress markers
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04766450
Brief Title
Effect of High-Dose NAC on Patients With DPN
Acronym
NAC
Official Title
Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the current study is to evaluate the efficacy and safety of high dose oral NAC (2400 mg/day divided into two doses) as an adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in patients with type 2 diabetes suffering from diabetic peripheral neuropathy.
Detailed Description
Patient written informed consent will be taken prior to study conductance
Lab assessment will be done at baseline and at the end of the study by withdrawing 7 ml of whole blood for assessment of following parameters: HbA1c, Liver & renal functions
Inflammatory markers including: Human Nuclear factor erythroid 2-related factor (NRF2) & Tumor necrosis factor alpha (TNF-α) using ELISA Kit
Oxidative stress markers: Glutathione Peroxidase using ELISA Kit
Inflammatory and oxidative stress marker samples will be stored at -80 for further evaluation using ELISA kit at the end of the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1, NAC group
Arm Type
Active Comparator
Arm Description
Group 1, NAC group (n=30): Patients will receive conventional therapy for diabetic neuropathy in addition to High Dose N-acetyl cysteine (2400 mg/day divided into two doses) daily for 3 months
Arm Title
Group 2, Control group
Arm Type
No Intervention
Arm Description
Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.
Intervention Type
Drug
Intervention Name(s)
Acetyl cysteine
Other Intervention Name(s)
N-acetyl cysteine
Intervention Description
NAC exhibits potent anti-oxidant activity in the cell through augmentation of intracellular GSH, which is a major component of the pathways by which cells are protected from OTS, and its direct scavenging activity of free radicals by providing sulfhydryl groups. Additionally, NAC treatment exhibits anti-inflammatory effects via inhibition of NF-κB activation and reducing subsequent cytokine production . Mitochondria-protective mechanisms of NAC may also be related to its anti-oxidant and anti-inflammatory properties
Primary Outcome Measure Information:
Title
Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
Description
Inflammatory marker
Time Frame
change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
Title
Concentration of Tumor necrosis factor alpha
Description
Inflammatory marker
Time Frame
Change from baseline tumor necrosis factor alpha at 3 months
Title
Concentration of Glutathione peroxidase
Description
Oxidative stress markers
Time Frame
Change from baseline glutathione peroxidase at 3 months
Other Pre-specified Outcome Measures:
Title
Michigan neuropathy screening instrument.
Description
Questionnaire of 15 yes or no questions. score of 13 or more means more neuropathic symptoms
Time Frame
At baseline and after 3 months
Title
Toronto clinical scoring system
Description
Questionnaire. as score increase means symptoms increase
Time Frame
At baseline and after 3 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).
Exclusion Criteria:
Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
Pregnancy or lactation or expecting to get pregnant during the study.
Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
Cancer patients.
Anyone having hypersensitivity to N-acetylcysteine.
Anyone already taking N-acetylcysteine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherien Emara, TA
Phone
01154089169
Email
sherienemara@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Farid Mohamed, Lecturer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamia El Wakeel, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Demerdash Hospital
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona AbdelSalam, Professor
12. IPD Sharing Statement
Links:
URL
https://doi.org/10.1016/j.tips.2013.01.001
Description
Berk, M., Malhi, G. S., Gray, L. J., & Dean, O. M. (2013). The promise of N-acetylcysteine in neuropsychiatry. Trends in Pharmacological Sciences, 34(3), 167-177.
Learn more about this trial
Effect of High-Dose NAC on Patients With DPN
We'll reach out to this number within 24 hrs